Avion Pharmaceuticals - Jefferies - The Global … Pharmaceuticals Avion Pharmaceuticals is a...

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Avion Pharmaceuticals Management Presentation June 2, 2014 Michael Sullivan - President

Transcript of Avion Pharmaceuticals - Jefferies - The Global … Pharmaceuticals Avion Pharmaceuticals is a...

Page 1: Avion Pharmaceuticals - Jefferies - The Global … Pharmaceuticals Avion Pharmaceuticals is a rapidly emerging leader as a specialty provider of unique women’s health products. In

Avion PharmaceuticalsManagement Presentation June 2, 2014

Michael Sullivan - President

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Disclaimer

Forward-looking statements (statements which are not historical facts) in this presentation are made

pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Forward-looking statements are not promises or guarantees and investors are cautioned that all

forward-looking statements involve risks and uncertainties, including but not limited to the impact of

competitive products and pricing, product demand and market acceptance, new product

development, the regulatory environment, including without limitation, reliance on key strategic

alliances, availability of raw materials, fluctuations in operating results and other results and other

risks which will be detailed from time to time in the Company's filings with the Securities and

Exchange Commission. These statements are based on management's current expectations and

are naturally subject to uncertainty and changes in circumstances. We caution you not to place

undue reliance upon any such forward looking statements which speak only as of the date made.

Avion is under no obligation to, and expressly disclaims any such obligation to, update or alter its

forward-looking statements, whether as a result of new information, future events or otherwise.

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Avion PharmaceuticalsA Branded Specialty Pharmaceutical Company

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Avion PharmaceuticalsExecutive Summary

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Avion Pharmaceuticals

Avion Pharmaceuticals is a rapidly emerging leader as

a specialty provider of unique women’s health products.

In contrast to similar-sized and similar-aged pharmaceutical companies, Avion’s

model allows the Company to pursue an innovative, long-term product

development strategy concurrent with an active, profitable and strategically

relevant participation in the market – maximizing today’s opportunities while

building for tomorrow. This model is built on 4 core principles:

• A low-overhead business structure

• Long term approach with existing products through creative life cycle

management

• An inquisitive and opportunistic acquisition strategy

• A hybrid long-term / short-term product development program

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Avion Pharmaceuticals Mission

Our goal is to become the leading Women’s Health and

Advanced Prescription Nutritional specialty

pharmaceutical company in the US.

We will provide products that deliver maximum benefit along the continuum of

care in women’s lives and those patients who can benefit from advanced

nutritional care. Understanding women’s health and matching products that

deliver positive support will help ensure improved lifestyles for women of all ages

and life stages and those paitent’s in need of advanced nutritional care.

At Avion, we work diligently to offer new delivery methods as well as

improvements to current products that will offer ease of use and adherence,

appropriate pricing with ease of access and beneficial health outcomes.

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Avion Accelerated Go-To-Market Strategy

1Identify gaps in women’s healthcare products and areas of opportunity in advanced nutritional care and develop distinctive solutions

2Source or develop unique and proprietary API to provide a compelling sales strategy while ensuring full protection

3

Commercialize products quickly, offer distinct competitive market advantages and strong business growth

4

Leverage dedicated experienced sales and marketing team to deliver flawless launch execution and rapid prescription uptake

5

Build continuing network of scientific and corporate partnerships, along with a vibrant Bus Dev initiative to drive opportunity identification, swift market entry and penetration -ensuring rapid market uptake and ongoing growth

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Avion Pharmaceuticals – Markets Served & Portfolio Distribution

75%

11%

13%

Percentage of Total Prescriptions Units By Segment

Women's Health

Hematinic

Dermatology

Source: IMS Health Dec. 2013

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Avion PharmaceuticalsOur People

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Our People

Mark Pugh

Chief Executive Officer

As Chief Executive Officer, Mark Pugh oversees the overall growth and

development of Avion Pharmaceuticals. Drawing from more than 20 years of

industry experience, Mr. Pugh has a documented record of success in

identifying and capturing new business opportunities to build high-profit, high-

growth corporations.

Prior to Acella, Mr. Pugh founded Alliant Pharmaceuticals, a pharmaceutical

company focused on the pediatric market. Alliant, which originated in 2004,

quickly grew to more than 120 employees within three years. The emerging

company was purchased by Sciele Pharmaceuticals in 2007.

Mr. Pugh's leadership in driving Alliant's growth earned the organization an

honorable mention by Catalyst Magazine as "one to watch," and Alliant

ranked #4 in Entrepreneur Magazine and PricewaterhouseCoopers’ “Hot 100”

ranking of the country’s fastest growing companies. In addition, Mr. Pugh was

selected in 2005 as one of the metro-Atlanta area’s “Top 40 Under 40” by the

Atlanta Business Chronicle and was the runner-up for the 2007 Ernst &

Young Entrepreneur of the Year Award.

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Our People

Harold A Deas, Jr.

Chief Operating Officer

In his role as Chief Operating Officer, Art Deas manages the day-to-day

operations for Avion Pharmaceuticals. Mr. Deas previously held the position

of Vice President, Sales and Marketing for Alliant Pharmaceuticals, and was

an integral component in the company’s overall success. Prior to Alliant, Mr.

Deas served as Regional Sales Manager for Genentech Pharmaceuticals.

Mike Sullivan

President

Mike Sullivan has over 20 years of prescription pharmaceutical sales and

marketing experience with specific responsibilities and expertise in sales

management, managed care, trade, sales operations, product management,

and training. Mike’s experience includes start-up expertise as well as success

in traditional pharma . He was responsible for the commercial development

and successful launch of Ther-Rx Corporation, a Specialty Pharmaceutical

start-up where he was the principal lead responsible for building the

commercial team charged with the successful launch of over eight (8) new

products during his ten (10) year tenure with the organization that generated

more than $250M in sales.

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Financial Summary - Primary Highlights

Gross Sales:•$28m (2012)•$42m (2013)•$57m (2014 projected)

EBITDA:• $13m (2012)•$15.5m (2013)•$21.5m (2014 projected)

Compound Annual Growth:• 147% (2013 vs. 2012)

Net Margin (2013)•95%Gross Margin (2013)•85%

$0

$5,000,000

$10,000,000

$15,000,000

$20,000,000

$25,000,000

2012 2013 2014(projected)

Annual EBITDA Trend

EBITDA

$0

$10,000,000

$20,000,000

$30,000,000

$40,000,000

$50,000,000

$60,000,000

2012 2013 2014(projected)

Annual Gross Sales Trend

Gross Sales

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Our People

Each District Manager has ten (10-13) Professional Sales Representatives

Art Deas

Chief Operating Officer

Mike Sullivan

President

Mark Steffen

Senior Director Trade and Managed

Care

Mary Claire Kenworthy

Senior Product Manager

Sakira Arora

Operations Manager

Magda Mocarski

Manager of Operations

Joe Fry

National

Sales Manager

Javaid Ahmed Northeast District

Manager

Frank DeRogatis Northeast District

Manager

Dan Nicastro Mid Atlantic District

Manager

Dena Courneen South District

Manager

Jen Scrutchfield Central District

Manager

Vacant

Southwest District Manager

Robert Sims South Central District

Manager

Shawn Bauer West Coast District

Manager

Karen Savage National Account

Manager

Carolyn Hill

Director of HR

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Our People

Leader Previous Company Years of Experience

Director of Trade and Managed Markets Sanofi – Ther-Rx Corporation 30

Director of Marketing Glaxo – Ther-Rx Corporation 18

National Accounts Director Advanced Biohealing -Sanofi – JSJ Derm 15

National Sales Director Sanofi – Shire - Sepracor 16

District Manager J&J - Ther-Rx – Azur Pharma 15

District Manager Ther-Rx Corp - Sucampo – Pernix Pharma 14

District Manager Biovail – Victory Pharma 17

District Manager Ther-Rx Pharmaceuticals 8

District Manager UCB – Ther-Rx Corp - Strativa 18

Manager of Human Resources Loreal – Eaton Energy 23

President UCB – Novartis - Sanofi- Ther-Rx Corp 18

The Avion leadership team has a unique blend of traditional pharma experience with a

documented track record of success in “Start-Up” Pharma and Specialty Pharma with a specific

therapeutic focus in Women’s Health, Dermatology, Nephrology, Oncology, and Hematology.

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Market and Opportunity

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Accelerated, Focused and Profitable

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Accelerated, focused and profitable.

Avion Pharmaceuticals is built on a model that delivers near

term profitability while building long-term value as an

important specialty provider of products serving an

evergreen category. There are 4 elements to this model:

• A low-overhead business structure

• An ongoing and active participation in the market

• An opportunistic acquisition strategy

• A hybrid long-term / short-term product development program

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• Run a low cost pharmaceutical model

– Pay for performance

– Streamlined Marketing Strategy

– Contract Manufacturing

– Third Party Logistics Provider

• Flawless Execution in Sales & Marketing

– 100 FTE’s, 8 RM’s (PHD’s)

– Ongoing sales training – The Avion Way

– Call on over 15800 OB-Gyns in the U.S.

• Maximize Sales Force Synergy

– Launch novel products for Women’s Health

– FerRivaFA™, Prenate® Mini, FaLessa™

• Acquire opportunistic Women’s Health products / companies

– Promotionally sensitive

– Opportunities for price increase

Accelerated, focused and profitable.

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Avion Low-Overhead Business Structure

Avion Pharmaceuticals leverages third parties to deliver

fundamental operations, along with exclusive licensing

agreements to secure proprietary rights to important IP

drug delivery and formulation technology.

• Contract Manufacturing

• 3PL

• Licensed specialty ingredients

• Licensed delivery technology

• National wholesaler presence and support

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Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4

2012 2013

Prenate MINI Promotion

launch

FeRiva launch

New Call Plan

Product

Launches

Xponent Data

Availability

1. Core Brands include PRENATE DHA®, ELITE®, and ESSENTIAL®

Sales Force

Size

30 FTE’s

CSO Reps 40 FTE’s

Organic Reps

83 FTE’s

Organic Reps

P1: Falessa

P2: MINI

P3: FeRiva

P1: MINI

P2: Core Brands

P1: MINI

P2: Core Brands

P1: Nicomide (Dermatologists)

CSO promotion starts

Avion Actively Participates in the Market – Chronology of Commercial Deployment

Q1 Q2 Q3 Q4

2014

100

Organic Reps

Falessa new product launch

New Call Plan

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Avion Opportunistic Business Development

• Acquire products from larger pharmaceutical companies that fit the core strategy – Women’s Health /

Dermatology

– Currently reviewing a suite of WH products from a larger company

• HRT

• Nutritionals

• Hematinic

• Other

• Validate and spearhead launches that will support unmet needs in women’s health market – i.e.

probiotics and breastfeeding

• Exclusive license of unique calcium API with patent and NDI approval, will be core API for new Prenate®

brands (Formical®)

• Exclusive license of unique iron API with patent and NDI approval, will be core for API for new Prenate

brands (Albion hematinic portfolio)

• In-license / acquire products from development companies both US / Ex US

– Injectable Iron

– Advanced oral iron

• Develop our own NDA products

– OC combo NDA

– Bacterial Vaginosis NDA

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Portfolio and Development Strategy

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For Every Step There is a Prenate ® – Continuum of Care for Women

Pre-

Conception

Intra-conception

Perio-Menopausal Post Menopausal/

Osteoporosis

IVFEndometriosis

Post Natal

Hormone Replacement

The Prenate Continuum of Care – Leveraging the prestige of the

Prenate brand across the lifespan of our patients – from pre-pregnancy to

post-menopausal. “We were there for you then; we’re there for you now”.

Pre-

conception

Pregnancy

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Avion Product Development

Avion pursues an integrated short-term / long-term approach to product

development designed to shorten commercialization cycles, enhance

overall portfolio value, and build Avion’s market presence and influence

in Women’s Health, Hematinic and Dermatology.

• Short Term Criteria

– Low barriers to entry

– Leverage exisiting sales

– Unique, protected

– Building block in our continuum strategy

• Long Term Criteria

– NDAs

– Unique high impact products

– Significant clinical application

– Narrow therapeutic indication

– Compliments our continuum of care

– Builds on our legacy and expertise

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Avion Product Launches for 2013 & 2014

Product Category Product Launch Market Size

Prenate Mini Q2-12 $160mm

Hematinic – OB (FeRiva) Q1-13 $250mm

Prenate Chewable Q1-13 $155mm

Prenate AM – Morning Sickness Q1-13 $195mm

Prenate Enhance – Advanced

FormulationQ2-14 $155mm

Prenate Restore Post Pregnancy

(Breastfeeding)Q3-14 $195mm

Falessa - (oral contraceptive) Q2-14 $3.8B

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Prenate® Franchise Historical Highlights

• Previously #1 prescribed prenatal vitamin in U.S.

• 1.8mm prenatal prescriptions generated in ‘09

• Most widely recognized and trusted brand in

prescription nutrition for women during pregnancy

• Three Original Prenate® brands

– Prenate® DHA

– Prenate® Essential

– Prenate® Elite

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Prenate® Product Launch Highlights

• New Product Launch – Prenate® Mini June 2012

– Prenate® Mini now the “fastest-growing” PNV in the entire branded and generic PNV

category (IMS NPA Data Dec. 7, 2012)

• Added Prenate® Chewable - May 2013

• Introduced Prenate® AM - August 2013

• Launched Prenate® Enhance & Prenate® Restore – November 2013. The

most advanced Prenatal and the first Postpartum Supplement with

Probiotics

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Avion Dermatology

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Avion Dermatology Portfolio

• Acquisition of Nicomide in 2011

– Generic competition removed providing exclusivity

– Field promotion August 2012

• Nicomide® - Allows HCPs to address one component of acne that

is currently not being treated with some of the other products

available – the inflammation.

• Nicomide – Natural supplement that works on mediating the

outward signs of inflammation – redness and swelling, as well as

the internal signs by preventing free fatty acids from forming can

cause of inflammation

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Avion Portfolio

NEW!! NEW!!

NEW!! NEW!!

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Avion Long-Term Pipeline Development Summary

Product Indication PhaseProjected

NDA Approval

Market Size

Oral Contraceptive Fe Oral contraception Phase 2 Q2 - 2016 $3.8B

Oral Contraceptive

Folic Acid

Oral contraception Phase 2 Q4 – 2016 $3.8B

Oral Contraceptive

FA – Fe

Oral contraception Phase 1 Q2 - 2017 $3.8B

Vaginal Delivery

Estrogen/Testosterone

Vaginal atrophy Pre-clinical Q1 – 2018 $250M

Combination BV/VVC

QD Dose Product

Vaginal infection Pre-clinical Q2 - 2017 $200M

Boric Acid 4.5% In a

Bioadhesive Vaginal

base

Vaginal infection Phase 2 Q4 - 2016 $150M

Pregnancy and Post-

Partum Hemorrhoid &

Vaginal Varicosity Care

Post and Pregnancy

related hemorrhoids

Phase 1 Q4 - 2017 $225M

Reference Market Size – approximation IMS data source

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Avion Acquisitions

Avion – An Integrated Growth Strategy

$

Avion NDAs

Avion Refomulations

• Short-Term Revenue Generation– Avion acquisitions on reformulations with patented API

– Avion Nutritionals

• Market Participation– Avion Sales Force Built on Advanced Nutritionals

– Hematology, Oncology, Nephrology, GI

• Innovation Drives Long Term Success– Avion NDAs

– Avion Strategic Acquisitions

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Right now, Avion has received 5 American Business (“Stevie”) Awards

• Prenate® Mini Marketing Campaign

Category: Marketing Campaign of the

Year – Pharmaceuticals

• Prenate® Mini Brand Experience

Category: Brand Experience of the Year

• Prenate Mini - Smallest Rx Prenatal

Vitamin

Category: Best New Product Of the Year

• Prenate Mini – Making it easy to take

Consumer Marketing Campaign of the

Year

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Avion Nominated for HDMA Diana Award 2014 – Manufacturer of the Year

A Commitment to Healthcare, Leadership and Innovation

HDMA’s Distribution Industry Award for Notable Achievements in Healthcare

(DIANA) has been the industry’s most recognized symbol of excellence since

1959. The award honors pharmaceutical and consumer product manufacturer

members that set the standard of excellence in new product introductions and

product promotions as well as build stronger business practices with HDMA

distributor members.

The DIANA Best Overall Manufacturer Award is a

distributor-driven nomination process. HDMA distributor members are asked

to nominate their top five manufacturer partners in each of the six categories.

HDMA will honor leading manufacturers with the DIANA on Monday, June

2, 2014, at its annual Business and Leadership Conference in Phoenix. The

awards will recognize HDMA associate manufacturer member companies

that strengthen their business partnerships with HDMA distributor members

by developing innovative, results-oriented business practices to bolster trade

relations and benefit the entire healthcare supply chain.

Nominations for these awards are submitted by HDMA’s distributor members

through Friday, March 28, 2014. DIANA winners join an elite circle of past

recipients who serve as models for leadership and innovation in the healthcare

marketplace and become part of the tradition of excellence that the DIANA has

fostered for more than a 50 years.

Join HDMA to celebrate and honor excellence in the healthcare supply chain!

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Summary

Avion Pharmaceuticals is uniquely positioned to leverage our product development innovation and recent success with the Prenate® Franchise to expand our therapeutic focus further into “other” Women’s Health therapeutic categories while also leveraging our product development innovation and acquisition strategy to leverage our Specialty Pharmaceutical market expertise to further expand into the hematology, oncology nephrology, and gastroenterology therapeutic categories.

Avion Pharmaceuticals is well positioned for continued and sustained growth through a proven portfolio development strategy and experienced commercial leadership team with a proven track record in building previously successful Specialty Pharmaceutical companies.